Patient Outcomes Using HIP7 Software as Compared to Conventional THA

Frequency of reduction of outliers* with Hip7 software as compared to conventional procedures (as defined by literature) using digital templating techniques for posterior and direct anterior approaches

*Outliers are defined as acetabular component placement outside the desired "safe zone". Two most commonly used safe zones are described by Lewinnek and Callanan with the inclination and anteversion values outlined below: Callanan Safe Zone -- Anteversion between 5-25 degrees, Inclination between 30-45 degrees. Lewinnek - Anteversion between 5-25 degrees, Inclination between 30-50 degrees [i.e. 40° ± 10° and 15° ± 10°].

The HOOS is developed as an instrument to assess the subject's opinion about their hip and associated problems. HOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

The OHS is a 12-item questionnaire for patients who undergo total hip replacement (THR) to complete. Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has four possible responses. Responses were from 1 = least difficult to 4= most difficult. Item scores are summed to give a total score from anywhere between 0 and 48. The lower the score, the better the outcome.

The EQ-5D-5L questionnaire consists of two parts. Part one is the descriptive system to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject indicates their health state by marking the most appropriate statement in each of the 5 areas. Responses are converted to scores ranging from less than 0 to 1.0 with high scores representing higher health utility. Part two is the EQ Visual Analog Scale (VAS) that records the subject's self-rated health on a vertical visual analogue scale. Scale ranges from 0-100 with 100 labelled "The best health you can imagine" and 0 "The worst health you can imagine".

To demonstrate cup placement accuracy (defined as the difference between inclination, anteversion, leg length, and offset target) from the Computerized Tomography [CT]).

A CT scan will assess pelvic tilt (angle of pelvic bone in relation to spine and femur)

Medical staff will measure angles of femur movement in order to assess active range of motion. Active range of motion measures include angles of active flexion, abduction, adduction, external rotation and internal rotation.

Whether the subject experienced femoral head dislocation will be assessed at 6 weeks post op. Femoral head dislocation will be determined based on the count of participants with joint dislocation responses recorded by the investigator in the Adverse Events Case Report Form (CRF).